Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00119444

Purpose

The purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET).

Condition	Intervention
Osteoarthritis	Procedure: Periacetabular osteotomy

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

changes in blood flow [ Time Frame: within the first three weeks after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

fluoride uptake [ Time Frame: within the first three weeks after operation ] [ Designated as safety issue: No ]

Estimated Enrollment:	14
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

osteotomy of the pelvis to increase acetabular coverage

Detailed Description:

As a consequence of periacetabular osteotomy the blood flow in acetabulum is decreased. After periacetabular osteotomy has been performed there is fine contact between the osteotomised acetabulum and the rest of the pelvis and the potential for healing is good. However, it has not been investigated how much the blood flow in acetabulum is changed after surgery. The blood flow is considered to be vital for how the pelvis heals after surgery. Most likely, the blood flow is important in relation to which degree osteoarthritis can be prevented after periacetabular osteotomy.

It is possible to estimate the blood flow by Positron Emission Tomography of the dysplastic hip joint pre- and postoperatively. In this study the blood flow and fluoride uptake is quantified by Positron emission tomography based on measurements of O-15 water and F-18 fluoride.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with radiologically diagnosed hip dysplasia (CE-angle < 25°).
Patients with osteoarthritis graded 0, 1 or 2 defined according to Tönnis' classification. Patients with pain from hip
Age > 18 years.
Minimum 110° flexion in hip joint and closed growth zones in the pelvic.
Informed consent.

Exclusion Criteria:

Patients with neurological diseases
Patients with calvé-Legg-Perthes syndrome.
Patients where an femoral intertrochanteric osteotomy is necessary.
Patients with medical sequelae after earlier hip surgery.
Females who are pregnant.
Patients with metal implants.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119444

Contacts

Contact: Inger B Mechlenburg, MScience	65371093 ext 45	INGER.MECHLENBURG@KI.AU.DK
Contact: Kjeld Søballe, MD, Prof.	89497425 ext 45	OVL09@as.aaa.dk

Locations

Denmark
Orthopaedic Center, Aarhus University Hospital	Recruiting
Aarhus, Denmark, 8000
Contact: Inger B Mechlenburg, MScience 65371093 ext 45 INGER.MECHLENBURG@KI.AU.DK
Sub-Investigator: Inger B Mechlenburg, MScience, PhD
Principal Investigator: Kjeld Søballe, MD, Prof.
Sub-Investigator: Flemming Hermansen, MD
Sub-Investigator: Theis Thillemann, MD

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Kjeld Søballe, MD, Prof.

Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

More Information

Responsible Party:	Aarhus Universityhospital ( Inger Mechlenburg, PhD )
Study ID Numbers:	20050606
Study First Received:	July 5, 2005
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00119444
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

PET
Periacetabular osteotomy

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009